CT-P44 (daratumumab biosimilar) / Celltrion - LARVOL DELTA

Celltrion gets EMA nod for phase 3 trial of Darzalex biosimilar (Korea Biomedical Review) - "The double-blind, randomized study will enroll 486 patients and compare CT-P44 with Darzalex Faspro in combination with lenalidomide and dexamethasone. The trial is expected to run for two years."

New P3 trial • Multiple Myeloma

A Study to Compare Pharmacokinetics, Efficacy and Safety of Subcutaneous CT-P44 and Darzalex Faspro in Combination With Lenalidomide and Dexamethasone in Patients With Refractory or Relapsed Multiple Myeloma (clinicaltrials.gov) - P3 | N=486 | Recruiting | Sponsor: Celltrion | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Malignancies • Multiple Myeloma • Oncology

A Study to Compare Pharmacokinetics, Efficacy and Safety of Subcutaneous CT-P44 and Darzalex Faspro in Combination With Lenalidomide and Dexamethasone in Patients With Refractory or Relapsed Multiple Myeloma (clinicaltrials.gov) - P3 | N=486 | Not yet recruiting | Sponsor: Celltrion

New P3 trial • Hematological Malignancies • Multiple Myeloma • Oncology

Celltrion files IND for phase 3 clinical trial of Darzalex biosimilar [Google translation] (Pharm E Daily) - "Celltrion announced on the 20th that it had applied for a domestic phase 3 clinical trial plan for the Darzalex biosimilar CT-P44 to the Ministry of Food and Drug Safety. This clinical trial will be conducted for two years on 486 patients with relapsed or refractory multiple myeloma."

New P3 trial • Multiple Myeloma

Celltrion receives FDA nod for phase 3 trial of Darzalex biosimilar (Korea Biomedical Review) - "Celltrion said Friday that it has received approval from the U.S. Food and Drug Administration (FDA) for the investigational new drug (IND) application to proceed with the global phase 3 clinical trial of its biosimilar to Janssen Biotech’s Darzalex (daratumumab), CT-P44....With this approval, Celltrion plans to initiate the global phase 3 trial involving 486 patients with relapsed or refractory multiple myeloma. The trial aims to demonstrate the similarity in pharmacokinetics, efficacy, and safety between Darzalex and CT-P44."

IND • New P3 trial • Multiple Myeloma

Celltrion files for phase 3 trial of new cancer biosimilar in US (The Investor) - "South Korean biopharmaceutical firm Celltrion said Monday it has submitted an investigational new drug application to the US Food and Drug Administration for a Phase 3 clinical trial of CT-P44, its new biosimilar candidate referencing Darzalex."

IND • New P3 trial • Hematological Malignancies • Multiple Myeloma • Oncology

Celltrion files European IND for phase 3 trial of Darzalex biosimilar (Korea Biomedical Review) - "Celltrion said Thursday that it has initiated phase 3 clinical trial procedures for CT-P44, its biosimilar to Janssen' Darzalex (daratumumab), a treatment for multiple myeloma....The company recently submitted an investigational new drug (IND) application for the global phase 3 trial to the European Medicines Agency's Clinical Trials Information System (CTIS). The trial will involve 486 patients with refractory and relapsed multiple myeloma, comparing the efficacy and safety of Darzalex and CT-P44."

IND • New P3 trial • Multiple Myeloma • Oncology